Self-collected Vaginal and Urine Samples in HIV-positive Women

August 27, 2024 updated by: University of Aarhus

Self-collected Cervical Cancer Screening Samples for Detection of Human Papillomavirus in HIV-positive Women - a Pilot Study of Self-collected Vaginal and Urine Samples

This study assesses topics as Human Immunodeficiency Virus (HIV), Human Papilloma Virus (HPV), and cancer screening methods. The focus will be on evaluating feasibility of implementing novel cancer screening modalities in a low-resource setting in Guinea-Bissau and further to estimate the prevalence of the precancerous virus HPV amongst women living with HIV. In the study the investigators will collect urinary and vaginal self-samples for HPV testing, and further evaluate the feasibility of implementing the devices as screening modalities through questionnaires given to the women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot study will partly take place at the outpatient HIV clinic, based in the Hospital National Simão Mendes (HNSM) in the capital city Bissau, Guinea-Bissau. HNSM is the main hospital in Bissau, and the HIV clinic is the biggest HIV treatment center in Guinea-Bissau in terms of patients on follow-up. The Bissau Nationwide HIV Cohort is a clinical HIV Cohort started in 2007. As of today, the investigators collect data from 9 outpatient HIV clinics in the country, and samples will be collected from all 9 clinics.

Study participants who present at the HIV clinic will be thoroughly instructed in correct usage of the vaginal and urine devices by trained healthcare workers. At the HIV clinics, facilities will be available for the women to conduct self-sampling in privacy, before handing in the samples. At the local laboratory, the dry brush head will be suspended in Thinprep medium and stored until shipment to Denmark. The urine samples will be stored at room temperature for up to 7 days before transferred to a -20º freezer until shipment to Denmark.

Analyses: vaginal and urine samples will be analyzed at Randers Regional Hospital using the Cobas 4800 HPV DNA test. The Department is specialized in self-collected samples from previous studies. This procedure is considered feasible based on data showing that the dry brush is analytically stable for HPV DNA detection for up to 32 weeks at temperatures ranging from 4 ºC to 30 ºC. After HPV analyses, residual material from the self-collected samples will be stored in a biobank in Denmark at Aarhus University hospital and saved for future research.

Study Type

Observational

Enrollment (Actual)

502

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guinea-Bissau
      • Bissau, Guinea-Bissau
        • Centro Tratamento Ambúlatorios na Guinea-Bissau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study is part of an international collaboration between the Department of Infectious Medicine at Aarhus University Hospital, the Bandim Health Project in Guinea-Bissau and Belgian researchers. Bandim Health project is a health and demographic surveillance system site that follows a population of more than 200.000 individuals in Guinea-Bissau. That population has created the base for the Guinea-Bissau Nationwide HIV-cohort with more than 35.000 patients.

The patients are provided free HIV-treatment and follow-up in the country. There is currently 9 large HIV-clinics in the country, and women presenting at these clinics will be invited to enroll if they meet the inclusion criteria.

Description

Inclusion Criteria:

  • HIV-positive (women with HIV-1, HIV-2 AND HIV1/2 are all eligible)
  • Age between 18 and 65 years

Exclusion Criteria:

  • Current pregnancy
  • Pregnancy within the last 3 months
  • Prior hysterectomy
  • Women using other vaginal products than contraceptives and water based lubricants
  • Women who don't understand the extent of the study
  • Bleeding due to ongoing period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV-positive females in Guinea-Bissau

The study is conducted on female HIV-infected patients in the Nationwide HIV-cohort at the 9 biggest HIV-clinics in Guinea-Bissau.

Participants will be invited to enroll in the project when they present to the HIV-clinics for HIV-treatment and consultations.
Diagnostic test: Self-sampling for HPV infection
After informed consent has been provided, the woman will be asked to collect firstly a first-void urine sample using the Collipee device and secondly to collect a vaginal self-sample using the dry Evalyn® Brush device. Socioeconomic, demographic and clinical data will be collected in the Bissau HIV Cohort database and through study questionnaires to collect background information on risk factors for HPV persistence and development of cervical cancer (HIV genotype, immune status, parity). Questionnaires will collect additional information on the acceptance of cervical screening measures to better evaluate the feasibility of implementing self-collected screening among HIV infected women in Guinea-Bissau.
Other Names:
  • Evalyn Brush
  • Collipee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of implementing HPV self sampling for cervical cancer screening
Time Frame: April 2023 - February 2024
Among women meeting the inclusion criteria, the investigators want to estimate the prevalence of how many accepts the offer to collect self-samples, thereby gaining knowledge on the feasibility of implementing self-sampling as a cervical cancer screening method in Guinea-Bissau.
April 2023 - February 2024
HPV-prevalence among HIV-infected women in Guinea-Bissau
Time Frame: April 2023 - February 2024
The investigators want to estimate the prevalence of high risk HPV infection among HIV-infected women in the Nationwide HIV-cohort in Guinea-Bissau.
April 2023 - February 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experiences with self-collected vaginal and urine samples
Time Frame: April 2023 - February 2024
Among the women accepting the invitation to enroll in the study, the investigators will through a questionnaire obtain data on the participants experiences with the two self-sampling devices.
April 2023 - February 2024
HPV-genotype agreement between vaginal- and urine samples
Time Frame: April 2023 - February 2024
Among HPV-positive women the investigators want to describe the genotype agreement among the two sample types
April 2023 - February 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Bandim Health Project
Universiteit Antwerpen
Randers Regional Hospital

Investigators

  • Principal Investigator: Sanne Jespersen, MD, PhD, Department of Infectious Diseases, Aarhus University Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Actual)

November 23, 2023

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R351-A20092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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